1. Field of the Invention
The present invention relates generally to surgical drapes. More particularly, the present invention relates to a surgical drape for use with a sterility maintenance cover.
2. Background Description
During certain surgical procedures, such as pacemaker implants and similar procedures, it is imperative that a patient's head be draped in a sterile manner to insure that a sterile field is maintained throughout the operation. Various methods have been employed to achieve this result, including various types of draping techniques, using supports and other devices. For example, U.S. Pat. No. 5,322,072 to Harrison et al. and U.S. Pat. No. 5,546,961 to Harrison (the “Harrison patents”) teach sterility maintenance covers that support a surgical drape over a patient's head. Such a sterility maintenance cover generally includes (i) a base panel for fitting under the head, neck and shoulders of a patient positioned on an examination or operating table, (ii) an upward-standing end panel extending from the base panel and having an open window for accessing the patient from the end or side of the table, and (iii) a cantilevered platform projecting horizontally from the end panel, substantially parallel to the base panel, over the patient's head and neck. In a preferred embodiment, the platform is designed to support a drape over a patient's head and/or to receive and retain or deploy various instruments used in the procedure. Also in a preferred embodiment, the sterility maintenance cover includes one or more windows to facilitate access to and observation of the patient's head.
As used herein, “sterility maintenance cover” refers to any structure that supports a surgical drape over a patient's head, preventing the drape from lying directly on the patient's face. Such sterility maintenance covers include sterility maintenance covers as described in the Harrison patents, as well as other similar devices such as three-dimensional frames.
Improper draping can cause serious problems and defeat the effectiveness of the sterility maintenance cover. For example, a conventional surgical drape applied insecurely over a sterility maintenance cover creates a substantial risk that the drape or a portion of it will move, exposing all or part of the patient's head during surgery. Various forces applied directly or indirectly to the drape by surgeons, assistants, instrumentation and the like may cause such movement. The exposure can contaminate a sterile field, increasing risk of infection, and expose the patient's head to blood and other bodily fluids.
Similarly, applying conventional flat sheet surgical drapes over a three-dimensional sterility maintenance cover may create unintended gaps, exposing all or part of the patient's head during surgery. Again, the exposure can contaminate a sterile field, increasing risk of infection, and expose the patient's head to blood and other bodily fluids.
Additionally, conventional surgical drapes, which do not include transparent windows or openings that correspond to windows or openings in a sterility maintenance cover, tend to visually conceal the patient's head in its entirety or substantial part. From the surgeon's perspective, such visual concealment may prevent observation of potential surgical problems and complications. For example, a nasal cannula or mask may come lose during surgery thereby preventing a patient from properly receiving supplemental oxygen and possibly trapping dangerous concentrations of oxygen under the drape. Even worse, a patient may vomit during surgery (e.g., if there is food in an anesthetized patient's stomach) with the stomach contents entering the windpipe and lungs, possibly causing pneumonia or even death. From the patient's perspective, particularly a patient who is awake at the start or throughout their surgery, such visual concealment deprives the patient of the opportunity to talk with the circulating nurse and may create a sense of claustrophobia, while contributing to anxiety and panic. Such emotional responses can adversely affect blood pressure and heart rate, which may also complicate a procedure.
Furthermore, conventional surgical drapes, which do not include openings that correspond to openings in a sterility maintenance cover, may cause unwanted increases in temperature and buildup of gasses. For example, a patient's exhalation under such a drape can make a patient feel warm, sweaty and uncomfortable. Concomitantly, levels of trapped carbon dioxide (CO2) (a prominent component of exhaled air) and/or supplemental oxygen may rise under the drape, creating substantial risks of hypercarbia and surgical fire, which may be sparked by electrosurgical units, lasers, certain drills, fiber optic devices, and electrocautery units.
Moreover, many conventional surgical drapes that include openings or apertures (more commonly known in the medical field as “fenestrations”) to facilitate surgical procedures have very limited utility when used in connection with a sterility maintenance cover. The fenestrations are typically located on the drape proximate to regions requiring surgical access. As such drapes typically do not include enough head-end material to drape over a sterility maintenance cover without causing the fenestrations to move away from the intended region, multiple drapes must be used. One drape may be used for the sterility maintenance cover, and another drape for the patient. Such draping, however, is inefficient and conducive to many of the draping problems discussed above.
Manually cutting a conventional drape with scissors or a knife to provide an opening creates similar problems. First, such manual operations consume valuable time and tend to be imprecise, often leading to improperly sized and placed openings. Oversized openings may compromise a sterile field and over-expose the patient's head to blood and fluids. Undersized and improperly placed openings visually conceal the patient's head, limit accessibility and risk trapping gases. Furthermore, such cutting may create rough, tattered or frayed edges that are conducive to lint generation. Fine pieces of lint may be inhaled by the patient, contaminate a sterile field and even enter the surgical site.
In sum, existing surgical drapes are not well suited for use with sterility maintenance covers, as they do not include attachment means for securing them to the sterility maintenance covers, lack sufficient head-end drape material to cover a sterility maintenance cover and omit features (e.g., cutouts and transparent windows) corresponding to openings and/or windows in the sterility maintenance covers. Consequently, use of conventional surgical drapes with a sterility maintenance cover, may give rise to the aforementioned serious risks. Thus, there is a need for a surgical drape that specifically accommodates sterility maintenance covers.